Listing of Color Additives Exempt from Certification; Mica-Based Pearlescent Pigments, 42271-42273 [05-14457]
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Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Rules and Regulations
to further flight. Do all actions in accordance
with the Accomplishment Instructions of
Boeing Special Attention Service Bulletin
747–53–2493, dated July 3, 2003.
Note 1: For the purposes of this AD, a
detailed inspection is: ‘‘An intensive
examination of a specific item, installation,
or assembly to detect damage, failure, or
irregularity. Available lighting is normally
supplemented with a direct source of good
lighting at an intensity deemed appropriate.
Inspection aids such as mirror, magnifying
lenses, etc., may be necessary. Surface
cleaning and elaborate procedures may be
required.’’
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. 1998C–0431] (formerly 98C–
0431)
Listing of Color Additives Exempt from
Certification; Mica-Based Pearlescent
Pigments
AGENCY:
ACTION:
Alternative Methods of Compliance
(AMOCs)
Material Incorporated by Reference
(h) You must use Boeing Special Attention
Service Bulletin 747–53–2493, dated July 3,
2003, to perform the actions that are required
by this AD, unless the AD specifies
otherwise. The Director of the Federal
Register approves the incorporation by
reference of this document in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. To
get copies of the service information, contact
Boeing Commercial Airplanes, P.O. Box
3707, Seattle, Washington 98124–2207. To
view the AD docket, go to the Docket
Management Facility, U.S. Department of
Transportation, 400 Seventh Street SW.,
room PL–401, Nassif Building, Washington,
DC. To review copies of the service
information, go to the National Archives and
Records Administration (NARA). For
information on the availability of this
material at the NARA, call (202) 741–6030,
or go to https://www.archives.gov/federal_
register/code_of_federal_regulations/ibr_
locations.html.
Issued in Renton, Washington, on July 11,
2005.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 05–14174 Filed 7–21–05; 8:45 am]
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The Food and Drug
Administration (FDA) is amending the
color additive regulations to provide for
the safe use of mica-based pearlescent
pigments as color additives in ingested
drugs. This action is in response to a
petition filed by EM Industries, Inc.
DATES: This rule is effective August 23,
2005. Submit written or electronic
objections and requests for a hearing by
August 22, 2005. See section VIII of the
SUPPLEMENTARY INFORMATION section of
this document for information on the
filing of objections.
ADDRESSES: You may submit written or
electronic objections and requests for a
hearing, identified by Docket No.
1998C–0431, by any of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Agency Web site: https://
www.fda.gov/dockets/ecomments.
Follow the instructions for submitting
comments on the agency Web site.
• E-mail: fdadockets@oc.fda.gov.
Include Docket No. 1998C–0431 in the
subject line of your e-mail message.
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier [For
paper, disk, or CD–ROM submissions]:
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
objections received will be posted
without change to https://www.fda.gov/
ohrms/dockets/default.htm, including
any personal information provided. For
detailed instructions on submitting
objections, see the ‘‘Objections’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.fda.gov/ohrms/dockets/
default.htm and insert the docket
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number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
¨
Aydin Orstan, Center for Food Safety
and Applied Nutrition (HFS–255), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1301.
SUPPLEMENTARY INFORMATION:
I. Introduction
Final rule.
SUMMARY:
(g)(1) The Manager, Seattle Aircraft
Certification Office (ACO), FAA, has the
authority to approve AMOCs for this AD, if
requested in accordance with the procedures
found in 14 CFR 39.19.
(2) An AMOC that provides an acceptable
level of safety may be used for any repair
required by this AD, if it is approved by an
Authorized Representative for the Boeing
Delegation Option Authorization
Organization who has been authorized by the
Manager, Seattle ACO, to make those
findings. For a repair method to be approved,
the repair must meet the certification basis of
the airplane, and the approval must
specifically refer to this AD.
BILLING CODE 4910–13–P
Food and Drug Administration,
HHS.
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In a notice published in the Federal
Register of June 22, 1998 (63 FR 33934),
FDA announced that a color additive
petition (CAP 8C0257) had been filed by
EM Industries, Inc., 7 Skyline Dr.,
Hawthorne, NY 10532 (now EMD
Industries, Inc.). The petition proposed
to amend the color additive regulations
to provide for the safe use of synthetic
iron oxide to color ingested drugs at
levels higher than the current limit and
to provide for the safe use of mica to
color ingested drugs. At the time of the
filing of the petition, FDA considered
the pigments that are the subjects of this
petition to be color additive mixtures of
synthetic iron oxide, mica, and titanium
dioxide. FDA did not include titanium
dioxide in the filing notice, because that
color additive was already listed for use
in ingested drugs. During its subsequent
review of the petition, the agency
determined that these pigments are
composite pigments, not color additive
mixtures. Therefore, the agency
published an amended filing notice in
the Federal Register of June 29, 1999
(64 FR 34816), to indicate that the
petition proposed to amend the color
additive regulations to provide for the
safe use of composite pigments prepared
from synthetic iron oxide, mica, and
titanium dioxide to color ingested
drugs.
The petitioner is seeking approval for
a maximum use level of the resulting
pigments of up to 3 percent by weight
in the finished drug product, and a
maximum iron oxide content no greater
than 55 percent in those pigments
containing iron oxide.
II. Manufacturing and Nomenclature
The subject color additives are
manufactured by preparing a
suspension of mica platelets, adding a
solution of soluble salts of titanium, of
iron, or of both, and a base to precipitate
titanium hydroxide, iron hydroxide, or
both onto the mica platelets. These
particles are then heated (calcined) at
temperatures up to 900 °C. During the
calcination, titanium hydroxide and
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Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Rules and Regulations
iron hydroxide are converted into
titanium dioxide, and iron oxide,
respectively. The agency has reviewed
the relevant data and information in the
petition relating to the manufacturing
and identity of the subject color
additives (Ref. 1), and to the proposed
uses of and estimated exposures to (Ref.
2) the subject color additives.
In a final rule published in the
Federal Register of October 24, 2002 (67
FR 65311), the agency listed in
§ 73.3128 (21 CFR 73.3128) the color
additives based on the first two
combinations given above (titanium or
iron salts and mica platelets) for use in
contact lenses. In the same final rule,
the agency collectively identified these
color additives as mica-based
pearlescent pigments. To be consistent
with § 73.3128, the agency is using the
same name for the color additives that
are the subjects of the present rule.
III. Safety Evaluation
To evaluate the safety of the proposed
uses of mica-based pearlescent pigments
for coloring ingested drugs, the agency
reviewed the toxicological data and
information submitted in the petition as
well as other information contained in
agency files (Ref. 3). In conjunction with
this review the agency notes that, based
on the chemical nature of these
inorganic pigments and their individual
components, as well as the available
solubility data contained in the petition,
the solubility of mica-based pearlescent
pigments in media relevant to human
health (e.g., digestive fluids in the
gastrointestinal tract) is expected to be
very low. As such, the bioavailability of
these pigments and/or their individual
components when ingested is also
expected to be low. Considering the
chemical nature of the pigments, and
their expected low solubility and
bioavailability, the agency concludes
that there is no toxic potential when
ingested at levels estimated by the
agency, based on their proposed use in
coloring ingested drugs. The agency also
notes that it has previously reviewed
various color additive uses of iron
oxide, titanium dioxide, and mica
where the additives would be ingested
and found such uses to be safe
(§§ 73.200, 73.575, 73.1200, 73.1496,
73.1575, 73.2250, 73.2496, and
73.2575).
Therefore, taking into account the
available safety information, the
insoluble nature of the subject color
additives, and the conservative
estimates of intake of the additives, the
agency concludes that the proposed use
of mica-based pearlescent pigments to
color ingested drugs is safe (Ref. 3).
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IV. Conclusion
Based on the data and information in
the petition and other relevant material,
FDA concludes that the petitioned use
of mica-based pearlescent pigments
prepared from synthetic iron oxide,
mica, and titanium dioxide to color
ingested drugs is safe. The agency
further concludes that the additives will
achieve their intended technical effect,
and are suitable for use in coloring
ingested drugs. The agency also
concludes that part 73 should be
amended as set forth in this document.
In addition, based upon the factors
listed in § 71.20(b) (21 CFR 71.20(b)),
the agency concludes that certification
of mica-based pearlescent pigments is
not necessary for the protection of the
public health.
V. Inspection of Documents
In accordance with § 71.15, the
petition and the documents that FDA
considered and relied upon in reaching
its decision to approve the petition are
available for inspection at the Center for
Food Safety and Applied Nutrition by
appointment with the information
contact person (see FOR FURTHER
INFORMATION CONTACT). As provided in
§ 71.15, the agency will delete from the
documents any materials that are not
available for public disclosure before
making the documents available for
inspection.
VI. Environmental Impact
The agency has previously considered
the environmental effects of this rule as
announced in the notice of filing for
CAP 8C0257 (63 FR 33934). No new
information or comments have been
received that would affect the agency’s
previous determination that there is no
significant impact on the human
environment and that an environmental
impact statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule contains no collections
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
VIII. Objections
This rule is effective as shown in the
DATES section of this document, except
as to any provisions that may be stayed
by the filing of proper objections. Any
person who will be adversely affected
by this regulation may file with the
Division of Dockets Management (see
ADDRESSES) written or electronic
objections. Each objection shall be
separately numbered, and each
numbered objection shall specify with
particularity the provisions of the
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regulation to which objection is made
and the grounds for the objection. Each
numbered objection on which a hearing
is requested shall specifically so state.
Failure to request a hearing for any
particular objection shall constitute a
waiver of the right to a hearing on that
objection. Each numbered objection for
which a hearing is requested shall
include a detailed description and
analysis of the specific factual
information intended to be presented in
support of the objection in the event
that a hearing is held. Failure to include
such a description and analysis for any
particular objection shall constitute a
waiver of the right to a hearing on the
objection. Three copies of all documents
are to be submitted and are to be
identified with the docket number
found in brackets in the heading of this
document. Any objections received in
response to the regulation may be seen
in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday. FDA will publish notice
of the objections that the agency has
received or lack thereof in the Federal
Register.
IX. References
The following references have been
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday.
1. Jensen, E., Memorandum entitled ‘‘Use
of Pearlescent Pigments as a Color Additive
in Tablets and Other Pharmaceutical
Preparations,’’ from the Division of Product
Manufacture and Use (HFS–246) to the
Division of Petition Control (HFS–215),
Center for Food Safety and Applied
Nutrition, FDA, January 21, 1999.
2. Lee, H. S., Memorandum entitled
‘‘Update of Intake Estimates,’’ from the
Division of Petition Review (HFS–265) to the
Division of Petition Review (HFS–265),
Center for Food Safety and Applied
Nutrition, FDA, November 24, 2004.
3. Taras, T. L., Memorandum entitled
‘‘Comprehensive Final Toxicology Evaluation
Memorandum: CAP 8C0257’’ from the
Division of Petition Review (HFS–265) to the
Division of Petition Review (HFS–265),
Center for Food Safety and Applied
Nutrition, FDA, December 20, 2004.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs,
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 73 is
amended as follows:
I
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Federal Register / Vol. 70, No. 140 / Friday, July 22, 2005 / Rules and Regulations
PART 73—LISTING OF COLOR
ADDITIVES EXEMPT FROM
CERTIFICATION
ENVIRONMENTAL PROTECTION
AGENCY
1. The authority citation for 21 CFR
part 73 continues to read as follows:
[FRL–7942–9]
I
Authority: 21 U.S.C. 321, 341, 342, 343,
348, 351, 352, 355, 361, 362, 371, 379e.
2. Section 73.1128 is added to subpart
B to read as follows:
I
§ 73.1128 Mica-based pearlescent
pigments.
(a) Identity. (1) The color additive is
formed by depositing titanium and/or
iron salts onto mica, followed by
heating to produce one of the following
combinations: Titanium dioxide on
mica; iron oxide on mica; titanium
dioxide and iron oxide on mica. Mica
used to manufacture the color additive
shall conform in identity to the
requirements of § 73.1496(a)(1).
(2) Color additive mixtures for drug
use made with mica-based pearlescent
pigments may contain only those
diluents listed in this subpart as safe
and suitable for use in color additive
mixtures for coloring ingested drugs.
(b) Specifications. Mica-based
pearlescent pigments shall conform to
the following specifications and shall be
free from impurities other than those
named to the extent that such other
impurities may be avoided by good
manufacturing practice:
(1) Lead (as Pb), not more than 4 parts
per million (ppm).
(2) Arsenic (as As), not more than 3
ppm.
(3) Mercury (as Hg), not more than 1
ppm.
(c) Uses and restrictions. Mica-based
pearlescent pigments may be safely used
to color ingested drugs in amounts up
to 3 percent, by weight, of the final drug
product. The maximum amount of iron
oxide to be used in producing said
pigments is not to exceed 55 percent, by
weight, in the finished pigment.
(d) Labeling. The label of the color
additive and of any mixture prepared
therefrom intended solely or in part for
coloring purposes shall conform to the
requirements of § 70.25 of this chapter.
(e) Exemption from certification.
Certification of this color additive is not
necessary for the protection of the
public health, and therefore batches
thereof are exempt from the certification
requirements of section 721(c) of the
Federal Food, Drug, and Cosmetic Act.
Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–14457 Filed 7–21–05; 8:45 am]
BILLING CODE 4160–01–S
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40 CFR Part 271
Idaho: Final Authorization of State
Hazardous Waste Management
Program Revision
Environmental Protection
Agency.
ACTION: Final rule.
AGENCY:
SUMMARY: Idaho applied to the United
States Environmental Protection Agency
(EPA) for final authorization of changes
to its hazardous waste program under
the Resource Conservation and
Recovery Act (RCRA). On May 16, 2005,
EPA published a proposed rule to
authorize the changes and opened a
public comment period. The comment
period closed on June 15, 2005. EPA has
decided that these revisions to the Idaho
hazardous waste management program
satisfy all of the requirements necessary
to qualify for final authorization and is
authorizing these revisions to Idaho’s
authorized hazardous waste
management program in today’s final
rule.
Final authorization for the
revisions to the hazardous waste
program in Idaho shall be effective at 1
p.m. E.S.T. on July 22, 2005.
FOR FURTHER INFORMATION CONTACT: Jeff
Hunt, Mail Stop AWT–122, U.S. EPA
Region 10, Office of Air, Waste, and
Toxics, 1200 Sixth Avenue, Seattle,
Washington 98101, phone (206) 553–
0256. E-mail: hunt.jeff@epa.gov.
SUPPLEMENTARY INFORMATION:
DATES:
A. Why Are Revisions to State
Programs Necessary?
States which have received final
authorization from EPA under RCRA
section 3006(b), 42 U.S.C. 6926(b), must
maintain a hazardous waste program
that is equivalent to and consistent with
the Federal program. States are required
to have enforcement authority which is
adequate to enforce compliance with the
requirements of the hazardous waste
program. Under RCRA Section 3009,
States are not allowed to impose any
requirements which are less stringent
than the Federal program. Changes to
State programs may be necessary when
Federal or State statutory or regulatory
authority is modified or when certain
other changes occur. Most commonly,
States must change their programs
because of changes to EPA’s regulations
in title 40 of the Code of Federal
Regulations (CFR) parts 124, 260
through 266, 268, 270, 273 and 279.
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42273
Idaho’s hazardous waste management
program received final authorization
effective on April 9, 1990 (55 FR 11015,
March 29, 1990). EPA also granted
authorization for revisions to Idaho’s
program effective on June 5, 1992 (57 FR
11580, April 6, 1992), on August 10,
1992 (57 FR 24757, June 11, 1992), on
June 11, 1995 (60 FR 18549, April 12,
1995), on January 19, 1999 (63 FR
56086, October 21, 1998), on July 1,
2002 (67 FR 44069, July 1, 2002), and
on March 10, 2004 (69 FR 11322).
Today’s final rule addresses a
program revision application that Idaho
submitted to EPA in September 2004, in
accordance with 40 CFR 271.21, seeking
authorization of changes to the State
program. On May 16, 2005, EPA
published a proposed rule announcing
its intent to grant Idaho final
authorization for revisions to Idaho’s
hazardous waste program and provided
a period of time for the receipt of public
comments. The proposed rule can be
found at 70 FR 25798.
B. What Were the Comments to EPA’s
Proposed Rule?
EPA received two letters during the
public comment period. One letter was
dated June 3, 2005, from Mr. Chuck
Broscious on behalf of the
Environmental Defense Institute and a
second letter was dated June 14, 2005,
from Mr. Chuck Broscious on behalf of
the Environmental Defense Institute,
Keep Yellowstone Nuclear Free, and
David B. McCoy, collectively the
commenters.
The comment letters focused on
issues originally raised in petitions
submitted to EPA on August 8, 2000,
and September 13, 2001, and on
numerous follow up letters and
correspondence related to those
petitions. The petitions themselves
centered on issues related to specific
units located at the Idaho National
Laboratory (INL) in Idaho Falls, Idaho.
The comment letters also raised a
concern about nuclear defense activities
at the same INL facility. In response to
this aspect of the commenters’ letter
EPA observes that defense activities
related to nuclear production and
propulsion programs will generally not
meet the definition of solid waste under
the RCRA regulations and may be
regulated by other federal authorities.
With respect to mixed waste, Idaho’s
hazardous waste program is authorized
for mixed waste.
In the September 13, 2001, petition
which commenters refer to in their
current comments, the commenters as
petitioners sought EPA’s withdrawal of
Idaho’s authorization to implement the
hazardous waste program under RCRA
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]]>Agencies
[Federal Register Volume 70, Number 140 (Friday, July 22, 2005)]
[Rules and Regulations]
[Pages 42271-42273]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-14457]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. 1998C-0431] (formerly 98C-0431)
Listing of Color Additives Exempt from Certification; Mica-Based
Pearlescent Pigments
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the color
additive regulations to provide for the safe use of mica-based
pearlescent pigments as color additives in ingested drugs. This action
is in response to a petition filed by EM Industries, Inc.
DATES: This rule is effective August 23, 2005. Submit written or
electronic objections and requests for a hearing by August 22, 2005.
See section VIII of the SUPPLEMENTARY INFORMATION section of this
document for information on the filing of objections.
ADDRESSES: You may submit written or electronic objections and requests
for a hearing, identified by Docket No. 1998C-0431, by any of the
following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 1998C-
0431 in the subject line of your e-mail message.
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All objections received will be
posted without change to https://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Aydin [Ouml]rstan, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1301.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notice published in the Federal Register of June 22, 1998 (63
FR 33934), FDA announced that a color additive petition (CAP 8C0257)
had been filed by EM Industries, Inc., 7 Skyline Dr., Hawthorne, NY
10532 (now EMD Industries, Inc.). The petition proposed to amend the
color additive regulations to provide for the safe use of synthetic
iron oxide to color ingested drugs at levels higher than the current
limit and to provide for the safe use of mica to color ingested drugs.
At the time of the filing of the petition, FDA considered the pigments
that are the subjects of this petition to be color additive mixtures of
synthetic iron oxide, mica, and titanium dioxide. FDA did not include
titanium dioxide in the filing notice, because that color additive was
already listed for use in ingested drugs. During its subsequent review
of the petition, the agency determined that these pigments are
composite pigments, not color additive mixtures. Therefore, the agency
published an amended filing notice in the Federal Register of June 29,
1999 (64 FR 34816), to indicate that the petition proposed to amend the
color additive regulations to provide for the safe use of composite
pigments prepared from synthetic iron oxide, mica, and titanium dioxide
to color ingested drugs.
The petitioner is seeking approval for a maximum use level of the
resulting pigments of up to 3 percent by weight in the finished drug
product, and a maximum iron oxide content no greater than 55 percent in
those pigments containing iron oxide.
II. Manufacturing and Nomenclature
The subject color additives are manufactured by preparing a
suspension of mica platelets, adding a solution of soluble salts of
titanium, of iron, or of both, and a base to precipitate titanium
hydroxide, iron hydroxide, or both onto the mica platelets. These
particles are then heated (calcined) at temperatures up to 900 [deg]C.
During the calcination, titanium hydroxide and
[[Page 42272]]
iron hydroxide are converted into titanium dioxide, and iron oxide,
respectively. The agency has reviewed the relevant data and information
in the petition relating to the manufacturing and identity of the
subject color additives (Ref. 1), and to the proposed uses of and
estimated exposures to (Ref. 2) the subject color additives.
In a final rule published in the Federal Register of October 24,
2002 (67 FR 65311), the agency listed in Sec. 73.3128 (21 CFR 73.3128)
the color additives based on the first two combinations given above
(titanium or iron salts and mica platelets) for use in contact lenses.
In the same final rule, the agency collectively identified these color
additives as mica-based pearlescent pigments. To be consistent with
Sec. 73.3128, the agency is using the same name for the color
additives that are the subjects of the present rule.
III. Safety Evaluation
To evaluate the safety of the proposed uses of mica-based
pearlescent pigments for coloring ingested drugs, the agency reviewed
the toxicological data and information submitted in the petition as
well as other information contained in agency files (Ref. 3). In
conjunction with this review the agency notes that, based on the
chemical nature of these inorganic pigments and their individual
components, as well as the available solubility data contained in the
petition, the solubility of mica-based pearlescent pigments in media
relevant to human health (e.g., digestive fluids in the
gastrointestinal tract) is expected to be very low. As such, the
bioavailability of these pigments and/or their individual components
when ingested is also expected to be low. Considering the chemical
nature of the pigments, and their expected low solubility and
bioavailability, the agency concludes that there is no toxic potential
when ingested at levels estimated by the agency, based on their
proposed use in coloring ingested drugs. The agency also notes that it
has previously reviewed various color additive uses of iron oxide,
titanium dioxide, and mica where the additives would be ingested and
found such uses to be safe (Sec. Sec. 73.200, 73.575, 73.1200,
73.1496, 73.1575, 73.2250, 73.2496, and 73.2575).
Therefore, taking into account the available safety information,
the insoluble nature of the subject color additives, and the
conservative estimates of intake of the additives, the agency concludes
that the proposed use of mica-based pearlescent pigments to color
ingested drugs is safe (Ref. 3).
IV. Conclusion
Based on the data and information in the petition and other
relevant material, FDA concludes that the petitioned use of mica-based
pearlescent pigments prepared from synthetic iron oxide, mica, and
titanium dioxide to color ingested drugs is safe. The agency further
concludes that the additives will achieve their intended technical
effect, and are suitable for use in coloring ingested drugs. The agency
also concludes that part 73 should be amended as set forth in this
document. In addition, based upon the factors listed in Sec. 71.20(b)
(21 CFR 71.20(b)), the agency concludes that certification of mica-
based pearlescent pigments is not necessary for the protection of the
public health.
V. Inspection of Documents
In accordance with Sec. 71.15, the petition and the documents that
FDA considered and relied upon in reaching its decision to approve the
petition are available for inspection at the Center for Food Safety and
Applied Nutrition by appointment with the information contact person
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 71.15, the
agency will delete from the documents any materials that are not
available for public disclosure before making the documents available
for inspection.
VI. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for CAP 8C0257 (63 FR
33934). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
VII. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VIII. Objections
This rule is effective as shown in the DATES section of this
document, except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
regulation may file with the Division of Dockets Management (see
ADDRESSES) written or electronic objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. Three copies of all documents are to be
submitted and are to be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will
publish notice of the objections that the agency has received or lack
thereof in the Federal Register.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Jensen, E., Memorandum entitled ``Use of Pearlescent Pigments
as a Color Additive in Tablets and Other Pharmaceutical
Preparations,'' from the Division of Product Manufacture and Use
(HFS-246) to the Division of Petition Control (HFS-215), Center for
Food Safety and Applied Nutrition, FDA, January 21, 1999.
2. Lee, H. S., Memorandum entitled ``Update of Intake
Estimates,'' from the Division of Petition Review (HFS-265) to the
Division of Petition Review (HFS-265), Center for Food Safety and
Applied Nutrition, FDA, November 24, 2004.
3. Taras, T. L., Memorandum entitled ``Comprehensive Final
Toxicology Evaluation Memorandum: CAP 8C0257'' from the Division of
Petition Review (HFS-265) to the Division of Petition Review (HFS-
265), Center for Food Safety and Applied Nutrition, FDA, December
20, 2004.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
73 is amended as follows:
[[Page 42273]]
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
0
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
0
2. Section 73.1128 is added to subpart B to read as follows:
Sec. 73.1128 Mica-based pearlescent pigments.
(a) Identity. (1) The color additive is formed by depositing
titanium and/or iron salts onto mica, followed by heating to produce
one of the following combinations: Titanium dioxide on mica; iron oxide
on mica; titanium dioxide and iron oxide on mica. Mica used to
manufacture the color additive shall conform in identity to the
requirements of Sec. 73.1496(a)(1).
(2) Color additive mixtures for drug use made with mica-based
pearlescent pigments may contain only those diluents listed in this
subpart as safe and suitable for use in color additive mixtures for
coloring ingested drugs.
(b) Specifications. Mica-based pearlescent pigments shall conform
to the following specifications and shall be free from impurities other
than those named to the extent that such other impurities may be
avoided by good manufacturing practice:
(1) Lead (as Pb), not more than 4 parts per million (ppm).
(2) Arsenic (as As), not more than 3 ppm.
(3) Mercury (as Hg), not more than 1 ppm.
(c) Uses and restrictions. Mica-based pearlescent pigments may be
safely used to color ingested drugs in amounts up to 3 percent, by
weight, of the final drug product. The maximum amount of iron oxide to
be used in producing said pigments is not to exceed 55 percent, by
weight, in the finished pigment.
(d) Labeling. The label of the color additive and of any mixture
prepared therefrom intended solely or in part for coloring purposes
shall conform to the requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic
Act.
Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14457 Filed 7-21-05; 8:45 am]
BILLING CODE 4160-01-S
